13th June 2019

Today the Department of Health and Social Care, the Welsh Government, the Scottish Government, and the Department of Health (Northern Ireland) have launched a public consultation relating to their proposal for the introduction of mandatory fortification of flour with folic acid in order to help reduce neural tube defects (NTDs) in fetuses by raising the blood folate levels of women who could become pregnant.

Folate (or vitamin B9) is a water soluble vitamin that functions together with vitamin B12 to form healthy red blood cells and is also required for normal cell division, the normal structure of the nervous system and specifically in the development of the neural tube in a developing fetus. Folate is present in many foods, including green leafy vegetables, such as broccoli, and Brussels sprouts, brown rice, peas, oranges and bananas. Folic acid (the synthetic form of folate) is voluntarily added to some foods such as breakfast cereals and yeast extract.

NTDs are birth defects of the brain, spine or spinal cord of the fetus (such as spina bifida) that arise during the first few weeks of pregnancy. It is estimated that about 1,000 NTD-affected pregnancies are diagnosed each year in the UK, though the total number is likely to be higher as some women will miscarry before diagnosis. NTDs can also result in termination, death shortly after birth or long term disability of the child. Folate deficiency increases the risk of NTDs and can also cause megaloblastic anaemia in men and women. The current advice for preventing NTDs is that women take a daily folic acid supplement if they could become, or plan to become, pregnant from preconception up until 12 weeks gestation. The recommended dose is 400 μg per day for most women but those who may be at higher risk of NTDs may be advised take 5 mg of folic acid per day. However, it is estimated that around half of all pregnancies are unplanned and there is evidence that supplementation advice is not being followed. Data from the National Diet and Nutrition Survey (years 7&8) suggests an estimated 90% of women aged 16-49 years have a folate status below the level recommended to reduce the risk of an NTD-affected pregnancy and in addition, an estimated 28% of girls aged 11-18 years, 15% of boys aged 11-18 years and 7% of adults have low blood folate levels, putting them at risk of anaemia.

More than 60 countries around the world (including Australia, Canada and the US, but no countries in the EU) have implemented mandatory fortification of flour with folic acid for the prevention of NTDs and have reported reductions in rates of NTDs of between 16% and 58% and no known adverse effects. The Scientific Advisory Committee on Nutrition (SACN) has recommended mandatory fortification of flour with folic acid for the UK several times previously (see reports published in 2006, 2009 and 2017), along with advice that this should be accompanied by restrictions on voluntary fortification of other foods with folic acid, and clear guidance on the use of folic acid supplements to ensure there is no increase in the numbers of people with intakes above the recommended upper level. On review of the evidence, SACN also concluded that there is no effect of folic acid supplementation on cognitive decline in older adults and that, overall, evidence does not suggest a detrimental effect of folic acid on cancer risk. There have been concerns that consistent high intakes of folic acid from supplements could potentially increase the risk of masking vitamin B12 deficiency in people with a condition known as pernicious anaemia. However, in February 2019 the Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) recommended that the maximum intake of folic acid from supplements should be 1 mg per day (1,000 μg) as there is little evidence that pernicious anaemia is masked at this level of intake.

Non-wholemeal wheat flour is suggested as a vehicle for folic acid due to its widespread consumption in the UK (an estimated 90% of adults consume products containing wheat flour such as pastries, cakes, biscuits, stuffing and gravy), however an estimated 29% of women consume very little bread. This would be in addition to the micronutrients already added to non-wholemeal wheat flour, iron, niacin (vitamin B3) and thiamin (vitamin B1), to restore nutrients lost during the milling process, plus calcium for health. Results of modelling work carried out by Food Standards Scotland suggests that mandatory folic acid fortification of flour would be expected to reduce the prevalence of low folate intakes, resulting in a reduction in the number of NTD-affected pregnancies and that a capping of voluntarily fortified foods and supplements would be expected to reduce the prevalence of intakes above the recommend upper level.

The consultation is open until 9th September 2019 and views are being sought on the following:

• Whether respondents agree or disagree with the proposal for mandatory fortification of flour with folic acid.
• Which types of flour (if any) should be fortified (e.g. just non-wholemeal wheatflour or all flour).
• Whether there are any alternative methods aiming to reduce the number of neural tube defects that could be introduced instead of fortification of flour.
• Whether individuals or businesses (including SMEs) could be negatively affected by the proposal and if so, how they could be supported.
• Whether, if the fortification of flour with folic acid is made mandatory, there should be limits on voluntary fortification of other food products and/or supplements with folic acid.
• Whether the provisional impact assessment (including cost/benefit analysis) is satisfactory and whether respondents have any proposed additions.
• Whether there are any practical issues for businesses or further trade implications that need to be considered.